Self-expanding valves yielded comparable 30-day mortality to balloon-expandable valves (1.4% vs 1.6%, P=1.00) but were associated with a higher permanent pacemaker implantation rate (12.7% vs 4.7%).
Cohort (n=257)
No
Does a self-expanding TAVR device compared to a balloon-expandable device improve procedural and 30-day outcomes in patients undergoing TAVR?
Short-term outcomes are equivalent between third-generation self-expanding and balloon-expandable TAVR devices, though self-expanding valves are associated with higher permanent pacemaker rates and longer hospital stays.
Absolute Event Rate: 1.4% vs 1.6%
p-value: p=1.00
OBJECTIVES: To evaluate balloon-expandable and self-expanding third-generation transcatheter aortic valve replacement (TAVR) devices according to patient selection criteria and outcomes. BACKGROUND: Two competing third-generation TAVR technologies are currently commercially available in the US. There are no published head-to-head comparisons of the relative performance of these two devices. METHODS: 257 consecutive patients undergoing TAVR with a third-generation balloon-expandable (Edwards Sapien 3) or self-expanding device (Medtronic CoreValve Evolut R) at a single US medical center were included. Choice of TAVR device was at the discretion of the multidisciplinary Heart Team. Baseline clinical characteristics, echocardiographic and CT imaging, procedural and 30-day outcomes were prospectively collected. RESULTS: 74 patients received a self-expanding valve (SEV) and 183 received a balloon-expandable valve (BEV). Patients selected for SEV were more frequently women, with lower body surface area and smaller calcified iliofemoral arteries. Three SEV patients required implantation of a second valve to successfully treat paravalvular leak. Only one BEV patient had moderate paravalvular regurgitation. There was no difference in the rate of stroke, major vascular complication or bleeding. Permanent pacemaker implantation rate was significantly higher with SEV (12.7% vs 4.7%, P = 0.49) and hospital length of stay was longer (8.3% vs 6.5%, P = 0.043), but 30-day mortality was comparable (1.4% vs 1.6%, P = 1.00). CONCLUSIONS: Short-term outcomes were equivalent between the two technologies. Clinically significant paravalvular regurgitation was rare. SEV were more frequently selected in women and patients with challenging transfemoral access, but were associated with higher permanent pacemaker implantation rate and longer hospital length of stay.
Rogers et al. (Thu,) conducted a cohort in Aortic stenosis requiring TAVR (n=257). Self-expanding valve (Medtronic CoreValve Evolut R) vs. Balloon-expandable valve (Edwards Sapien 3) was evaluated on 30-day mortality (p=1.00). Self-expanding valves yielded comparable 30-day mortality to balloon-expandable valves (1.4% vs 1.6%, P=1.00) but were associated with a higher permanent pacemaker implantation rate (12.7% vs 4.7%).
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